Devices for forming and/or maintaining connections between adjacent anatomical conduits

ABSTRACT

Implantable connector devices which are useable to maintain fluidic connection between, or approximation of, openings formed in adjacent natural or prosthetic anatomical conduits (or adjacent openings formed in a single anatomical conduits). These connector devices generally comprise a plurality of radially expandable annular members having one or more elongate strut members extending therebetween. Initially, the device is mountable on or within a delivery catheter while in a radially compact configuration. After the delivery catheter has been inserted into the body, the device is caused to transition to a radially expanded configuration whereby it becomed implanted within the body so as to maintain the desired fluidic connection between, or the desired approximation of, the anatomical conduit(s).

RELATED APPLICATIONS

[0001] This application is a continuation-in-part of co-pending PCTInternational Application No. PCT/US97/01468 filed on Jan. 31, 1997, andof co-pending U.S. patent application Ser. Nos. 08/730,327 filed on Oct.11, 1996 and 08/730,496 filed on Oct. 11, 1996. The entire disclosure ofeach such related application is expressly incorporated herein byreference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to medical devices andmethods, and more particularly to devices and methods for formingconnections or facilitating flow between openings formed in adjacentlysituated anatomical conduits.

BACKGROUND OF THE INVENTION

[0003] In modern medical practice, it is sometimes desirable to formflow-through connections (e.g., passageways or flow channels) betweenadjacent anatomical conduits (natural or prosthetic), or betweenadjacent segments of a single anatomical conduit. The types of naturaland prosthetic anatomical and conduit(s) which may be linked by suchflow-through connections include; blood vessels, vas deferens, fallopiantubes, intestines, lymphatic ducts, grafts, etc.

[0004] In particular, U.S. patent application Ser. Nos. 08/730,327 and08/730,496 have described certain methods and devices for performingtransluminal, catheter-based, bypass procedures wherein flow-throughconnections are formed between two adjacently situated anatomicalconduits (e.g., blood vessels) to bypass a diseased, injured orobstructed segment of one of those anatomical conduits, using a segmentof the adjacent conduit as the bypass loop. These procedures includecatheter based, transluminal, in situ coronary vein bypass procedureswherein at least one primary flow-through connection (i.e., bloodflowpassageways) is formed between an obstructed coronary artery and anadjacent coronary vein, such that blood will flow from the obstructedartery into the adjacent coronary vein. The arterial blood which hasflowed into the coronary vein may then be allowed to retroperfuse theischemic myocardium by retrograde flow through the coronary vein. Or,alternatively, one or more secondary flow-through connections may beformed between the coronary vein and the obstructed artery at site(s)downstream of the obstruction (or some other coronary artery), therebyallowing the arterial blood which had flowed into the coronary vein toreenter the obstructed artery (or some other coronary artery), afterhaving bypassed the arterial obstruction.

[0005] Also, International Patent Publication No. WO 97/27897 describescertain thoracoscopic or minimally invasive methods for by-passing anobstructed coronary artery by maneuvering, into juxtaposition with theobstructed artery, a tubular graft. Openings are formed in thejuxtapositioned graft and in the adjacent artery, at sites upstream anddownstream of the obstruction. The graft is then connected to the arterysuch that the openings in the graft are positioned in alignment with,and in fluidic connection with, the openings in the artery. Blood maythen flow through the flow-through connections between the tube graftand the artery, thereby bypassing an obstructed region of the artery.

[0006] Additionally, U.S. Pat. No. 3,042,021 (Read), entitled BypassType Insert Plug For Body Passageway, describes a procedure wherein anapparatus is used to connect or facilitate flow between openings formedin adjacent anatomical passageways (e.g., genitourinary ducts), whichare situated in side-to-side juxtaposition.

[0007] Also, U.S. Pat. No. 5,443,497 (Venbrux), entitled PurcutaneousProsthetic ByPass Graft and Method of Use, describes a device forbypassing an occluded lumen or for coupling two lumens, and relatedmethods for installing such device(s) within the body.

[0008] At least some of the previously described procedures for formingflow-through connections (e.g., passageways or flow channels) betweenadjacent anatomical conduits may be accomplished by a transluminal,catheter-based approach which avoids the need for open surgical exposureand dissection of the involved anatomical passageways. Such transluminalprocedures generally require the passage of a flexible cannula orcatheter through the lumen of one of the involved body passageways,deploying or actuating a tissue penetration element from the catheter,through the wall of the passageway in which the catheter is positioned,and into the adjacent passageway to which the side to side connection isto be made. In at least some of these transluminal, catheter-basedprocedures, it is additionally desirable to install a connectorapparatus to maintain the desired alignment of the flow-through openingsin the adjacent anatomical conduits, and/or to prevent the leakage ofbody fluid into the surrounding tissues or spaces. Some connectorapparatus of this type have previously been described in U.S. patentapplication Ser. Nos. 08/730,327 and 08/730,496 as well as InternationalPatent Publication No. WO 97/27898 entitled “Methods and Apparatus forConnecting Openings Formed in Adjacent Blood Vessels or Other AnatomicalConduits”. However, none of these previously described methods orapparatus appear to be of optimal design for all clinical applications.

[0009] Accordingly, there exists a need in the art for the design anddevelopment of new apparatus for connecting or maintaining alignment offlow-through openings formed in adjacent blood vessels or otheranatomical conduits. It is further desirable that such connectorapparatus be implantable by a transluminal, catheter-based technique toavoid the need for open surgical exposure of the affected anatomicalconduits.

SUMMARY OF THE INVENTION

[0010] The present invention includes devices and methods forconnecting, or facilitating flow between, adjacently situated anatomicalor prosthetic conduit(s) (e.g., openings in separate anatomical conduitsor two openings at different locations in the same anatomical conduit).The connector devices of the present invention include certain“two-annular-member” embodiments and “three-annular-member” embodiments,as described more fully herebelow.

[0011] In accordance with the invention, there is provided atwo-annular-member connector device which is implantable within the bodyof a mammal to facilitate flow between (i.e, to maintain alignmentand/or connection between) a first opening formed in an anatomicalconduit (e.g., a first blood vessel), and a second opening formed in ananatomical conduit (e.g., an opening formed in a second blood vessel ora second opening formed in the first blood vessel). Thistwo-annular-member connector device generally comprises (a) at least oneproximal radially expandable annular member, (b) at least one distalradial expandable annular member, (c) at least one strut memberconnected to and extending between the proximal and distal annularmembers. Prior to implantation in the body, this two-annular-memberconnector device is disposed in a collapsed disposition with itsproximal and distal annular members in their radially collapsedconfigurations and its strut member(s) in a pre-expansion configuration.In this collapsed disposition, the connector device is sufficientlycompact to be mounted upon or within a delivery catheter which istransluminally advancable to site of intended implantation. After thedelivery catheter has been transluminally advanced to the site ofintended implantation, the connector device is released or separatedfrom the delivery catheter, its proximal and distal annular members areexpanded to their radially expanded configurations, and its strutmember(s) caused or permitted to assume a post-expansion (i.e., curved)configuration. In this manner the connector device may be implanted withits proximal annular member(s) at a first location in an anatomical orprosthetic conduit (e.g., a first blood vessel), its distal annularmember(s) at a second location in an anatomical or prosthetic conduit(e.g., a second blood vessel or a second location within the first bloodvessel), and its strut member(s) extending therebetween. When soimplanted, the two-annular-member connector device may serve to maintainthe patency, alignment and/or approximation of the first and secondopenings--and of any interstitial tunnel, passageway or bypass conduitcreated or disposed between such openings.

[0012] Further in accordance with the invention, there is provided athree-annular-member connector device which is implantable within thebody of a mammal to facilitate flow between (i.e, to maintain alignmentand/or connection between) a first opening formed in an anatomicalconduit (e.g., a first blood vessel), and a second opening formed in ananatomical conduit (e.g., an opening formed in a second blood vessel ora second opening formed in the first blood vessel). Thisthree-annular-member connector device generally comprises (a) at leastone proximal radially expandable annular member, (b) at least one distalradially expandable annular member, (c) at least one medial radiallyexpandable annular member, (d) at least one first strut member connectedto and extending between the proximal and medial annular members, and(e) at least one second strut member connected to and extending betweenthe medial and distal annular members. This device is initiallymountable upon or in a deliver catheter while in a collapsed dispositionwherein the proximal, distal and medial annular members are in radiallycompact configurations and the strut members are in “pre-expansion”configurations. Thereafter the device is transitioned to an implantationdisposition wherein the proximal, distal and medial annular members arein their radially expanded configurations and the strut member(s) are intheir “post-expansion” (e.g., curved) configurations. This results inthe connector device being implanted with its proximal annular member(s)at a first location in an anatomical or prosthetic conduit (e.g., withina first blood vessel), its distal annular member(s) at a second locationin an anatomical or prosthetic conduit (e.g., within a second bloodvessel or a second location within the first blood vessel), and itsmedial annular member(s) located within or between the first and secondopenings of the anatomical or prosthetic conduit(s). When so implanted,the three-annular-member connector device may serve to maintain thepatency, alignment and/or approximation of the first and secondopenings--and of any interstitial tunnel, passageway or bypass conduitcreated or disposed between such openings.

[0013] Still further in accordance with the invention, in either thetwo-annular-member or three-annular-member connector devices, the actualnumber of annular members present (i.e., in excess of two (2) or three(3)) may be determined by functional considerations, such as the amountof scaffolding of support required to maintain the desired patency andapproximation of the flow channels, and/or the specific position atwhich the device is to be implanted within the body.

[0014] Still further in accordance with the invention, any embodiment ofthe connector device of the present invention may be fully or partiallycovered by a pliable covering (e.g., woven polyester, expandedpolytetrafluoroethylene (ePTFE), polyurethane, etc.) to channel, direct,block, or otherwise control the flow of body fluid and/or to improve thebiological compatibility of the connector device. Additionally oralternatively, such covering may be formed of material which willpromote or prevent proliferation of the adjacent tissue. In someapplications, the covering may be formed of material which willbiodegrade or become absorbed after it has served its intended purpose.Flow through holes or openings may be formed at selected locations insuch pliable covering to direct or permit the desired flow of body fluidthrough the device. Such flow-through holes or openings may be formed inthe covering prior to implantation of the connector device, or may beformed in situ following implantation of the connector device.

[0015] Still further in accordance with the present invention, theannular members and/or strut member(s) of the connector devices may beformed of a resilient material which is initially compressible andconstrainable such that the annular members are in their radiallycollapsed states and the strut member(s) are in their pre-expansionconfigurations but which, when unconstrained, will self-expand to aconfiguration wherein the annular members are expanded and the strutmember(s) are in their post-expansion configurations. Alternatively, theannular members and/or strut member(s) of the connector devices may beformed of a malleable (e.g., plastically deformable) material which isinitially formed such that the annular members are in their radiallycollapsed states and the strut member(s) are in their pre-expansionconfigurations but which, when outward radial pressure is exertedthereagainst, will plastically deform to a configuration wherein theannular members are expanded and the strut member(s) are in theirpost-expansion configurations..

[0016] Still further in accordance with the invention, the connectordevices may be implanted in various different orientations orarrangements and/or my be purposely formed or deformed in a manner whichwill exert a traction force upon the surrounding tissue. Such tractionforce may be utilized to cause sloping or curvature of the openingsformed in the first and second anatomical conduits and/or anysurrounding tissue, to promote non-turbulent, laminar flow of blood orother body fluid between the anatomical conduits. In this regard, theinvention includes methods (described in detail herebelow), for placingthe connector devices in opposing orientations so as to cause two (2)adjacent interstitial passageways to angle or slope toward one anotherto promote non-turbulent flow therethrough.

[0017] Further aspects and advantages of the present invention will beapparent to those skilled in the art, after reading and understandingthe detailed description of preferred embodiments set forth herebelow,and after viewing the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018]FIG. 1a is a schematic showing of adjacent anatomical conduitswhich have an interstitial passageway formed therebetween and atwo-annular member connector device of the present invention disposedtherewithin.

[0019]FIG. 1b is a schematic showing of adjacent anatomical conduitswhich have an interstitial passageway formed therebetween and athree-annular member connector device of the present invention disposedtherewithin.

[0020]FIG. 1c is a perspective view of a two-annular-member connectordevice of the present invention in a fully assembled, operativeconfiguration.

[0021]FIG. 1d is a perspective view of a three-annular-member connectordevice of the present invention in a fully assembled, operativeconfiguration.

[0022]FIG. 2 is a plan view of a preferred two-annular member connectordevice of the present invention disposed in a flattened, pre-assemblyconfiguration.

[0023]FIG. 2a is an enlarged perspective view of segment 2 a of FIG. 2,showing an alternative hinged connection formed between the strutmembers and the annular member componnet(s) of the connector device.

[0024]FIG. 2b is an enlarged perspective view of segment 2 b of FIG. 2,showing optional interconnecting members of a first type formed betweenadjacent strut members of the connector device.

[0025]FIG. 2c is an enlarged perspective view of segment 2 c of FIG. 2,showing optional interconnecting members of a second type formed betweenadjacent strut members of the connector device.

[0026]FIG. 2d is an enlarged perspective view of segment 2 d of FIG. 2,showing optional curved regions formed in the strut members of theconnector device to provide for adjustability in length of the device.

[0027]FIG. 3 is a plan view of a preferred three-annular memberconnector device of the present invention, disposed in a flattened,pre-assembly configuration.

[0028]FIG. 4a is a side elevational view of a delivery catheter markerof the present invention disposed in a first rotational orientation,accompanied therebeneath by a schematic showing of a connector device ofthe present invention in a corresponding first rotational orientation.

[0029]FIG. 4b is a side elevational view of a delivery catheter markerof the present invention disposed in a first rotational orientation,accompanied therebeneath by a schematic showing of a connector device ofthe present invention in a corresponding third rotational orientation.

[0030]FIG. 4c is a side elevational view of a delivery catheter markerof the present invention disposed in a third rotational orientation,accompanied therebeneath by a schematic showing of a connector device ofthe present invention in a corresponding third rotational orientation.

[0031]FIGS. 5a-5 c are step-wise, schematic showings of a deliverycatheter which incorporates a marker of the present invention, beingused to deliver a connector device of the present invention to form aconnection between adjacently situated anatomical conduits in whichopenings have been formed.

[0032]FIG. 6a is a perspective view of a connector device of the presentinvention having an optional covering formed thereon, with flow-throughopenings formed at selected locations in the covering.

[0033]FIG. 6b is a perspective view of a connector device of the presentinvention having an option partial covering formed thereon, suchcovering being substantially confined to the mid-portion of the device..

[0034]FIGS. 7a-7 e are step-wise schematic showings of a method for insitu formation of the flow-through openings in the covered connectordevice of FIG. 6, after the connector device has been implanted withinadjacent anatomical conduits.

[0035]FIGS. 8a-8 e are step-wise schematic showings of the performanceof one transluminal procedure to bypass of an arterial obstruction usinga segment of an adjacent vein as an in situ bypass conduit, and whereinthe connector devices of the present invention are implanted in opposingorientations to facilitate smooth, laminar blood flow through the veinsegment.

[0036]FIGS. 9a-9 e are step-wise schematic showings of the performanceof another transluminal procedure to bypass of an arterial obstructionusing a segment of an adjacent vein as an in situ bypass conduit, andwherein the connector devices of the present invention are implanted inopposing orientations to facilitate smooth, laminar blood flow throughthe vein segment.

[0037]FIGS. 10a-10 j are step-wise schematic showings of the performanceof another transluminal procedure to bypass of an arterial obstructionusing a segment of an adjacent vein as an in situ bypass conduit, andwherein the connector devices of the present invention are implanted inopposing orientations to facilitate smooth, laminar blood flow throughthe vein segment.

[0038]FIGS. 11a-11 e are step-wise schematic showings of the performanceof another transluminal procedure to bypass of an arterial obstructionusing a segment of an adjacent vein as an in situ bypass conduit, andwherein a single connector device of the present invention, whichincorporates a partial covering thereon, is implanted such that a) itsproximal and distal annular members are disposed in a single artery atlocations upstream and downstream of an obstruction, b) its strutmembers extend through a segment of an adjacent vein, and c) itscovering serves to block to outflow of blood into venous side brancheswhich emanate from the segment of vein.

[0039]FIG. 12 shows the manner in which body fluid (e.g., blood) mayflow between the strut members of certain embodiments of the connectormembers of the present invention.

[0040]FIG. 13 is a perspective view of a connector device of the presentinvention implanted within a bifurcated anatomical conduit.

[0041]FIG. 14 is a schematic, elevational view of adjacent anatomicalconduits having a single passageway formed therebetween and athree-annular-member connector device (which includes more than oneproximal annular member and more than one distal annular member)implanted within the passageway such that it extends into bothanatomical conduits.

[0042]FIG. 15 is a schematic, elevational view of adjacent anatomicalconduits having two interstitial passageways formed therebetween and theconnector device of FIG. 14 implanted therein such that one end of thedevice extends into one of the anatomical conduits and the other end ofthe device is positioned within one of the interstitial passageways.

[0043]FIG. 16 is a schematic, elevational view of adjacent anatomicalconduits having two interstitial passageways formed therebetween andtwo-annular-member connector device implanted therein such that one endof the device extends into one of the anatomical conduits and the otherend of the device is positioned within one of the interstitialpassageways.

[0044]FIG. 17 is a schematic, elevational view of adjacent anatomicalconduits having two interstitial passageways formed therebetween and thetwo-annular-member connector device of FIG. 16 implanted therewithinsuch that one end of the device terminates in one of the interstitialpassageways and the other end of the device terminates within the otherinterstitial passageway.

[0045]FIG. 18 is a schematic showing of the anatomical “Brouck-Moscheau”having i) a first interstitial passageway formed between the Circumflexcoronary artery and the Great Cardiac Vein, ii) a second interstitialpassageway formed between the Anterior Interventricular Vein and theLeft Anterior Decending coronary artery, and iii) connector devices ofthe present invention disposed within those first and secondinterstitial passageways to facilitate coronary revascularization.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] The following detailed description and the accompanying drawingsare provided for purposes of describing and illustrating presentlypreferred embodiments and/or examples of the invention only, and are notintended to limit the scope of the invention in any way.

[0047] A. Structure and Function of the Two-Annular Member andThree-Annular Member Connector Devices

[0048]FIG. 1a shows, in schematic fashion, a two-annular memberconnector device 10 of the present invention operatively implanted so asto maintain connection between a first opening OP₁ formed in the wall ofa first anatomical conduit AC₁ and a second opening OP₂ formed in theadjacent wall of a second anatomical conduit AC₂ This two-annular memberconnector device 10 generally comprises proximal and distal radiallyexpandable annular members 12 a, 12 b having a plurality of strutmembers 14 extending therebetween. As shown, the proximal annular member12 a may be positioned within the lumen of the first anatomical conduitAC₁ so as to frictionally engage the surrounding wall of that anatomicalconduit AC₁, the distal annular member 12 b is positioned within thelumen of the second anatomical conduit AC₂ so as to frictionally engagethe surrounding wall of that anatomical conduit AC₂ , and the strutmembers 14 extend through the respective first and second openings OP₁,OP₂ . In this manner, the connector device 10 forms a connection betweenthe first and second anatomical conduits AC₁, AC₂ and maintains thefirst and second openings OP₁, OP₂ in alignment with one another suchthat body fluid (e.g., blood) may flow therethrough.

[0049] FOG. 1 b shows, in schematic fashion, a three-annular memberconnector device 10′ of the present invention operatively implanted soas to maintain connection between a first opening OP₁ formed in the wallof a first anatomical conduit AC₁, and a second opening OP₂ formed inthe adjacent wall of a second anatomical conduit AC₂. This three-annularmember connector device 10′ generally comprises proximal, distal andmedial radially expandabe annular members 12 a, 12 b, 12 c. A pluralityof first strut members 14 a extend between the proximal annular member12 a and the medial annular member 12 c. A plurality of second strutmembers 14 b extend between the medial annular member 12 c and thedistal annular member 12 b. As shown, the proximal annular member 12 amay positioned within the lumen of the first anatomical conduit AC₁ soas to frictionally engage the surrounding wall of that anatomicalconduit AC₁, the distal annular member 12 b is positioned within thelumen of the second anatomical conduit AC₂ so as to frictionally engagethe surrounding wall of that anatomical conduit AC₂, and the medialannular member 12 c is positioned within the passageways or openingsOP₁, OP₂ formed in the walls of the adjacent anatomical conduits AC₁,AC₂ and/or within any intervening tissue (e.g., connective tissue,muscle, etc.) which may reside between the first and second anatomicalconduits AC₁, AC₂. In this manner, the three-annular member connectordevice 10′ forms a connection between the first and second anatomicalconduits AC₁, AC₂ and maintains the first and second openings OP₁, OP₂in alignment with one another such that body fluid (e.g., blood) mayflow therethrough. Additionally, in this three-annular-memberembodiment, the medial annular member 12 c provides additionalscaffolding or support for tissue which surrounds the first and secondopenings OP₁, OP₂ to maintain patency of the flow-through passagewayand/or may act as a bulkhead or barrier to deter or prevent body fluid(e.g., blood) from infiltrating or leaking into the region between theadjacent anatomical conduits AC₁, AC₂.

[0050] The two-annular-member connector device 10 or thethree-annular-member connector device 10′ may be formed at leastpartially of resilient material which is preformed and biased to acurvilinear shape (e.g., a serpentine shape having a first curve in onedirection and a second curve in another direction) as shown in FIGS. 1aand 1 b. Alternatively such devices 10, 10′ may be of a flexible orhinged construction which will allow them to assume the desired curved(e.g., serpentine) configuration when implanted. Also, as shown in FIG.11e and described more fully herebelow, the two-annular-member connectordevice 10 may be preformed to a multicurvate shape wherein the struts 14are preformed or formable to a generally “U” shaped configuration suchthat the proximal and distal annular members 12 a, 12 b may reside atspaced apart locations in the first anatomical conduit AC₁, and thestrut members 14 extend through the first and second passageways oropenings OP₁, OP₂ and through the adjacent segment of the secondanatomical conduit (e.g., a vein which lies adjacent to an obstructedartery) which is being used as an in situ bypass conduit.

[0051]FIG. 1c is a more detailed showing of the preferredtwo-annular-member connector device 10 of FIG. 1a. In this preferredembodiment, the proximal and distal annular members 12 a, 12 b comprisealternating (e.g., zig-zag or sinusoidal) elongate members 16 which,when in their radially expanded configuration, have linear portions 18and apices 20 which define a generally cylindrical annular shape. Four(4) strut members 14 are included in this embodiment. The opposite endsof each strut member 14 are connected to the inboard apices 20 of thealternating elongate members 16 which make up each annular member 12 a,12 b, as shown. In this manner, the strut members 14 combine with thealternating elongate members 16 to define a longitudinal flow-throughspace FS through which a biological fluid (e.g., blood) may flow. Alongitudinal axis LA is projectable through this device, when in itsradially expanded implantation configuration, as shown in FIG. 1c.

[0052]FIG. 1d is a more detailed showing of the preferredthree-annular-member connector device 10 of FIG. 1b. In this preferredembodiment, the proximal, distal and medial annular members 12 a, 12 b,12 c comprise alternating (e.g., zig-zag or sinusoidal) elongate members16 which, when in their radially expanded configuration, have linearportions 18 and apices 20 which define a generally cylindrical annularshape. Four (4) strut members 14 are included in this embodiment. Theopposite ends of the strut members 14 a, 14 b are connected to theadjacent apices 20 of the alternating elongate members 16 which make upeach annular member 12 a, 12 b, 12 c, as shown. In this manner, thestrut members 14 a, 14 b combine with the alternating elongate members16 to define a longitudinal flow-through space FS through which abiological fluid (e.g., blood) may flow. A longitudinal axis LA isprojectable through this device, when in its radially expandedimplantation configuration, as shown in FIG. 1d. It should also beappreciated that by varying the width of the strut members 14, theamount of radial force imparted by the strut members 14 against thetissue can be varied in accordance with the amount of force required tomaintain patency of the flowpath in the subject anatomy.

[0053] The connector devices 10, 10′ may be fabricated in any suitableway, of any suitable material. For example, the connector devices 10,10′ may be cut (e.g., laser cut) from a solid, cylindrical tube, or theymay be fabricated from wire or other suitable strand-like material.FIGS. 2 and 3 show flattened views of specific connector devices 10, 10′of the present invention, which have been cut from a solid, cylindricaltube by presently known laser cutting technology. The tube is preferablyformed of resilient or superelastic material, such as a nickel-titaniumalloy containing 50.8 atomic % nickel/balance titanium.

[0054] The showings of FIGS. 2 and 3 depict preferred connector devices10, 10′ in their radially compact configurations after having undergonea hypothetical flattening maneuver—i.e., a maneuver whereby a straightcut is formed longitudinally in each device 10, 10 a, and the device 10,10′ is then unrolled from its original cylindrical configuration to aflat configuration.

[0055] In the embodiment shown in FIG. 2, some of the alternatingelongate members 16 s (i.e., the “selected” alternating elongatemembers) of each annular member 12 a, 12 b may be wider incross-dimension and/or of greater mass than the other alternatingelongate members 16 n (i.e., the “non-selected” alternating elongatemembers). Because the selected alternating elongate members 16 s arewider and/or of greater mass than the other non-selected alternatingelongate members 16 n, the selected alternating elongate members 16 swill diverge (i.e., separate or spread) further away from each otherthan will the non-selected alternating members 16 n, as the device 10 or10′ self-expands to its radially expanded configuration. As a result,the corresponding selected strut members 14 s which are attached to theapices 20 s of the selected alternating elongate members 16 s,will alsoseparate further apart than the other non-selected strut members 14 n.Thus, when the device 10 is in its radially expanded implantationconfiguration, the separation distance D_(s) between the selected struts14 s will be greater than the separation distance D_(n) betweennon-selected struts 14 n. In this manner, the device 10 may be implantedin a specific rotational orientation wherein the intended flow of bloodor other body fluid will pass between the selected struts 14 s and theincreased separation distance D_(s) therebetween will minimize thefrictional drag or disruption of flow which would or could occur if theselected struts 14 s were within the fluid flow path. Although thisaspect of the invention is shown in relation to FIG. 2, it will beappreciated that this aspect of the invention may be incorporated intoany embodiment of the two-annular member or three-annular memberconnector drvice 10, 10′ wherein the structure of the device willpermit.

[0056] The strut members 14 may be rigidly connected to (e.g., formedcontinuously with or fused to) the inboard apices 20 of the annularmembers 12 a, 12 b as shown in FIG. 2, or alternatively such strutmembers 14 may be flexibly connected to (e.g., connected by hinged orpivotal connection) to the inboard apices 20 as shown in FIG. 2a. Inembodiments wherein the strut members 14 are rigidly connected to theinboard apices 20, it will be desirable for the strut members to beformed or formable to a curved (e.g. serpentine) shape which conforms tothe shape of the surrounding anatomy at the intended site ofimplantation. In other embodiments wherein the strut members 14 areflexibly connected to the inboard apices 20, the strut members may beformed or formable to a straight or minimally curved configuration tofacilitate transluminal delivery of the device 10, as these flexibleconnections between the strut members 14 and annular members 12 a, 12 bwill automatically pivot or flex so as to conform to the shape of thesurrounding anatomy within which the device 10 is implanted. Althoughthis aspect of the invention is shown in relation to FIG. 2, it will beappreciated that this aspect of the invention may be incorporated intoany embodiment of the two-annular member or three-annular memberconnector device 10, 10′ wherein the structure of the device willpermit.

[0057] Also, as shown in FIGS. 2b and 2 c, some or all of the strutmember(s) 14 may be connected to neighboring strut member(s) 14 bylinking members 30 a or 30 b. These linking members 30 a, 30 b may serveto selectively control or limit the distance of separation Ds or Dn ofthe adjacent strut members 14 and/or may provide increased scaffoldingto prevent surrounding tissue (e.g., intervening connective tissue ormuscle which resides between the anatomical conduits) from lapsing,invading or ingrowing into the flow-through space FS. As shown in FIGS.2b and 2 c these linking members 30 a, 30 b may be of curved or V-shapedconfiguration, and those linking members 30 a in one portion (e.g., theproximal half) of the connector device 10 may be directed in a directionX, which is opposite the direction Y in which those linking members 30 bin another portion of the connector device (e.g., the distal half) aredirected. The acute internal angle of each such “V” shaped linkingmember 30 a, 30 b will decrease as the separation distance Ds betweenthe adjacent strut members 14 increases. Although this aspect of theinvention is shown in relation to FIG. 2, it will be appreciated thatthis aspect of the invention may be incorporated into any embodiment ofthe two-annular member or three-annular member connector device 10, 10′wherein the structure of the device 10, 10′ will permit.

[0058] Also, as shown in FIG. 2d, some or all of the strut members 14may incorporate spaced-apart curved segments 32 which diverge laterallyfrom the longitudinal axis AX_(strut) of the strut 14. These curvedsegments 32 may be arcuate (e.g., generally U shaped) and may be spacedequidistantly from one another. These curved segments 32 provideincreased scaffolding to prevent surrounding tissue (e.g., interveningconnective tissue or muscle which resides between the anatomicalconduits) from lapsing, invading or ingrowing into the flow-throughspace FS.

[0059] In the preferred connector device 10′ shown in FIG. 3, the strutmembers 14 b which extend from the distal annular member 12 b passlongitudinally through the medial annular member 12 c and are attachedthereto at locations L on the proximal aspect of the medial annularmember 12 c, thereby causing the structure of the medial annular member12 c to be more dense (i.e., less porous) than the proximal or distalannular members 12 a, 12 b. Such increased density of the medial annularmember will provide a regionalized increase or concentration ofscaffolding to prevent tissue which surrounds the medial annular member12 c (e.g., intervening connective tissue or muscle which residesbetween the anatomical conduits) from lapsing, invading or ingrowinginto the flow-through space FS which passes through the medial annularmember 12 c. This optional aspect of the invention may be particularlydesirable in applications where the tissue which surrounds the medialannular member 12 c is likely to undergo proliferation (e.g., formationof granulation tissue) or in-growth which could occlude or decrease thepatency of the flow space FS. Although this aspect of the invention isshown specifically in relation to FIG. 2, it will be appreciated thatthis aspect of the invention may be incorporated into any embodiment ofthe two-annular-member or three-annular-member connector device 10, 10′wherein the structure of the device 10, 10′ will permit.

[0060] As also shown in FIG. 3, in some embodiments of the invention,some of the strut members 14 a (crv), 14 b (crv) may be longer than theother strut members 14 a, 14 b, and may incorporate one or more waves orcurves while in ther pre-expansion configuration. These strut members 14a (crv), 14 b (crv) will typically be required to navigate a largerradius of curvature than the other strut members 14 a, 14 b which arelocated laterally across from them. Thus, these strut members 14 a(crv), 14 b (crv) have a curve or wave form built in while in theirpre-expansion configurations, and such curve or wave form will elongate(e.g., relax or become shallower) as the device 10 transitions to itsexpanded, implantation configuration and the excess length of thosestrut members 14 a (crv), 14 b (crv) which become elongated willaccommodate the increased radius of curvature which they are required tonavigate as device 10 is implanted.

[0061] B. Methods and Devices for Precise Rotational Orientation ofDelivery Catheter used for Implantation of Connector Devices HavingPreformed Curved Configuration

[0062] In embodiments of the invention wherein the connector device 10,10′ has a preformed, curved configuration as shown in FIG. 1c, it willoften be desirable to preposition the delivery catheter used to deliverthe connector device 10, 10′ in a specific rotational orientation toensure that the connector device 10, 10′ will be properly oriented whenit is expelled from the delivery catheter 48.

[0063] i. Marker(s) on Delivery Catheter

[0064] Markers on the delivery catheter 48 may be specificallypositioned and/or configured to provide an indication of thelongitudinal placement of the connector 10, 10′ within the catheter.Such markers may then be utilized as the delivery catheter 48 is placedacross the passageway between the anatomical conduits, to allot theoperator to determine where the ends of the connector device 10, 10′will ultimately be placed when the device 10, 10′ is implanted.

[0065] Additionally, the delivery catheter 48 may incorporate at leastone marker 50 which indicates the particular rotational orientation inwhich the connector device 10, 10′ has been loaded into the catheter 48.As shown in FIGS. 4a-4 c, such marker 50 may comprise a band having anotch 52 formed at a specific location thereon. The band of this marker50 may be formed of any suitable material capable of being imaged ordetected by the type of imaging or detection system being used (e.g.,x-ray, fluoroscopy, ultrasound, Doppler, MRI, etc.) For example, themarker 50 may be formed of radiopaque or radiodense metal or plasticwhich may be imaged by fluoroscopy. The location of the notch 52signifies or marks a predetermined location or point P on the connectordevice 10, 10′.

[0066] ii. Marker(s) on Connector Device

[0067] At least one second imagable marker 23 capable of being imaged bythe particular imaging system avaliable diring the procedure (e.g.,x-ray, fluoroscopy, ultrasound, Doppler, MRI, etc.) may be formed on thedistal end of the connector device 10, 10′ at location P. These markers23, 50 may then be used by the operator to facilitate implantation of adevice 10, 10′ having a preformed curvature, in its proper orientationof curvature, as illustrated by FIGS. 5a-5 c and described more fullyherebelow.

[0068] iii. Method for Using Markers to Ensure Correct RotationalOrientation of Preformed Connector Device Prior to Implantation

[0069] With particular reference to FIGS. 5a-5 c, a connector device 10having strut members 14 which are preformed to a desired curvilinearconfiguration, is preferably sufficiently resilient to be compressibleto a substantially straight, radially compact configuration whereby itmay be loaded into the lumen of a delivery catheter 48. When the device10 is loaded into the delivery catheter 48, a core member 54 will bepositioned within and/or behind the device 10 to prevent the connectordevice 10 from retracting in the proximal direction within the deliverycatheter 48.

[0070] The connector device 10 having preformed curved strut members 14may be oriented within the catheter 48 such that the second marker 23 onpoint P of the connector device 10 is next to the notch 52 of thecatheter marker 50. The catheter 48 is then advanced through the lumenof a first anatomical conduit AC₁ through previously formed openingsOP₁, OP₂, and into the lumen of the second anatomical conduit AC₂, asshown in FIG. 5a. Thereafter, the catheter 48 is rotated underradiographic visualization (e.g., fluoroscopy) until the notch 52 ofmarker 50 is located adjacent the wall of the second anatomical conduitAC₂ directly (i.e., 180 degrees) opposite the location of the secondopening OP₂. Thereafter the core member 54 is held in longitudinallyfixed position the prevent proximal retraction of the connector device10, and the catheter 48 is slowly retracted in the proximal direction.As the catheter 48 is retracted, the first annular member 12 a willinitially become uncovered by the catheter 48 such that it may radiallyexpand. As the distal end of the first annular member 12 a is uncoveredby the retracting catheter 48, the operator may check the position ofthe marker 23 on the distal end of the device 10 (i.e., on the distalannular member 12 a) to confirm that the device 10 is in its desiredrotational orientation. If the rotational orientation of the device isdetermined to be improper, the operator may halt further retraction ofthe catheter 48 and may make further adjustment of its rotationalorientation before the first annular member 12 a becomes fully radiallyexpanded. After the proper rotational orientation of the connectordevice 10, 10′ has been confirmed by the positioning of the secondmarker 23, the catheter 48 will be further retracted such that thecurved strut(s) 14 and any third annular member 12 c (if present) extendas desired through the openings OP₁, OP₂ and the second annular member12 b becomes deployed and radially expanded within the lumen of thesecond anatomical conduit AC₂.

[0071] Those skilled in the art will recognize that these aspects of thepresent invention, and particularly the use of visible markers to effectthe desired orientation and positioning of the connector device 10 atthe time of implantation, may be accomplished in accordance with thecatheter-orienting/ positioning techniques (e.g., techniques which usean accompanying intravascular ultrasound imaging catheter (IVUS))described in co-pending U.S. patent application Ser. No. 08/837,294filed on Apr. 11, 1997, the entire disclosure of such co-pendingapplication being expressly incorporated herein by reference.

[0072] C. Full or Partial Covering of Connector Devices

[0073] As shown in FIG. 6a-6 b, any of the two-annular member orthree-annular member connector devices 10 (covered) may be fully orpartially covered by a pliable covering 60, 60 (partial). Such covering60, 60(partial) may be formed of any suitable material, such as apolymer film (expanded polytetrafluoroethylene (ePTFE) or polyurethane)or a fabric (e.g., woven polyester). Such covering 60, 60(partial) maybe disposed upon and supported by the annular members 12 a, 12 b, 12 cand/or the strut members 14 a, 14 b, 14 a (crv), 14 b (crv). Suchcovering 60, 60(partial) may form a barrier about all or a portion ofthe flow space FS defined within the connector device 10 (covered). Inthis regard, such optional covering 60, 60(partial) may serve to: i)prevent direct contact between the annular members 12 a, 12 b, 12 cand/or strut members 14 a, 14 b, 14 a(crv), 14 b(crv) and the adjacenthost tissue to i) improve the biocompatability of the connector device10(covered), ii) minimize the potential for immunologic graft-hostresponses; iii) prevent body fluid from leaking or infiltrating intospaces or tissues which surround the connector device 10 (covered); iv)channel or direct the flow of body fluid in desired directions or intodesired anatomical structures; V) prevent or deter tissue proliferation,ingrowth or invasion of tissue into the flow space FS defined within theconnector device 10(covered) and/or vi) distribute any outwardlydirected force created by the connector device 10, 10′ over the adjacentsurface of the anatomical conduit(s), thereby minimizing the potentialfor localized erosion or perforation of the anatomical conduits by theimplanted connector device 10(covered). Also, in some embodiments suchas that shown in FIG. 11, the covering 60, 60 (partial) may extendtransversely through the device, or may be otherwise positioned, tofully or partially block the flow of body fluid (e.g., blood) in acertain direction or through a certain portion of the device.

[0074] The physical and material properties of the covering 60, 60(partial) my vary depending on the intended application and mode ofdeployment of the device 10 (covered). In some embodiments, the covering60 may be formed of material which is sufficiently elastic to expand tothe radially expanded diameter of the device 10(covered) and to contractto the radially contracted diameter of the device I 0(covered) withoutcreating substantial slack in the material of the covering 60. In otherembodiments wherein the covering 60 does not have such range ofelasticity, it is preferable that the covering 60 be attached to ordisposed on the annular members 12 a, 12 b, 12 c and or the strutmembers 14 a, 14 b, 14 a(crv), 14 b(crv) such that any slack which formswhen the device 10(covered) is in its radially compact configuration,may be folded, furled or compressed in a manner which will reduce suchslack to a small diameter close to or equal to that of the radiallycompact annular members 12 a, 12 b, 12 c, thereby facilitating thedesired transluminal passage of the device 10(covered).

[0075] In some embodiments, the full or partial covering 60, 60(partial) may be formed of material which is capable of being imaged bythe type of imaging system being utilized during the procedure (e.g.,x-ray, flouroscopy, MRI, ultrasound, Doppler, etc.). For example, thecovering 60, 60(partial) may be impregnated with BaSO₄ so as to beradiographically imaged, thereby allowing the operator to place thecover 60, 60(partial) in a desired location, and also allowing the cover60, 60(partial) to continue to act as a marker of a specific location(e.g., the location of a flow-through passageway between anatomicalconduits) subsequent to completion of the interventional procedure.

[0076] D. In Situ Modification of the Strut Member(s) and/or Covering toForm or Promote A Desired Flow Path Through the Connector Device

[0077]FIGS. 7a-7 e show a method which may be used for formingopening(s) in the plaiable cover 60 of a covered connector device 10(covered). It will be further appreciated, however, that this method mayalso be used to effect in situ deformation or separation of adjacentstrut members 14 a, 14 b, 14 a (crv), 14 b (crv) of any connector device10, 10′, 10 (covered) in order to promote nonturbulant, laminar flow ofbody fluid (e.g., blood) between those strut members 14 a, 14 b, 14 a(crv), 14 b(crv).

[0078] Referring to FIG. 7a, after the connector device 10 (covered) hasbeen implanted in the desired first and second anatomical conduits AC1,AC2, a separate catheter 66 having a cover-puncturing distal tip 67 anda balloon 68 may be advanced through the covering 60 at adesired|location (see FIG. 7b) and the balloon 68 may then be inflatedto form a desired flow-through opening 62 a, 62 b in the covering 60 ofthe connector device 10 (covered). It is to be appreciated that,although FIGS. 7a-7 e show a procedure for the in situ formation offlow-through openings 62 a, 62 b in the covering 60, essentially thesame procedure using the catheter 66 (without the puncturing distal tip67) and its balloon 68 may be used to accomplish in situ bending ordeformation of the strut members 14, 14 a, 14 b, 14 a(crv), 14 b(crv) ofany covered connector device 10 (covered) or non-covered connectordevice 10, 10′ of the present invention, for the purpose of improvingflow of body fluid, or improving the stability with which the device 10,10′, 10(covered) is implanted.

[0079] E. Use of the Connector Devices to Exert Traction Upon or CauseDeformation of Surrounding Tissue

[0080] In some applications of the invention, it may be preferable forthe connector device 10, 10′, 10 (covered) to exert some traction orforce upon surrounding tissues to modify (e.g., remodel, move,reconfigure, compress or otherwise reshape) the surrounding tissues.This aspect of the invention may be particularly useable to minimize thesharpness of comers or bends in an anatomical flow channel or passagewayso as to minimize turbulence and/or promote laminar flow through thechannel or passageway. In some instances, the desired traction force maybe created by implanting two (2) of the connector devices 10, 10′, 10(covered) in opposite orientations, as described more fully in theexamples provided herebelow.

[0081] In other applications where the un-scaffolded channels orpassageways have been formed at the desired angle (e.g., anon-perpendicular angle relative to the longitudinal axis of one of theanatomical conduits), and the curved shape of the connector device(s)10, 10′ and/or the placement of the connector devices 10, 10′ inopposite orientations, may be utilized as a means of minimizing theamount of traction upon, or the deformation of, the surrounding tissue.

[0082] i. A method wherein a single delivery catheter is used to implanttwo connector devices, in opposite orientations

[0083]FIGS. 8a-8 e show an example of an approach wherein a singledelivery catheter 48 is used to deliver and implant two (2) connectordevices 10 in opposite orientations, as shown.

[0084] In addition to 1.) holding the adjacent anatomical conduits AC₁,AC₂ in desired positions relative to each other and ii.) maintaining thepatency of the openings OP₁, OP₂ in the anatomical conduits AC₁, AC₂ andany intervening tissue positioned therebetween, the connector devices10, 10′ of the present invention may additionally create a desiredtraction force upon the openings OP₁, OP₂ and any surrounding oradjacent tissue, to effect a desired deformation or shaping of the flowpassageways created between the anatomical conduits AC₁, AC₂. Suchdeformation or shaping of the flow passageways may serve to minimizeturbulence of the body fluid (e.g. blood) as it flows through the insitu bypass conduit created by a segment of the second anatomicalconduit AC₁, AC₂.

[0085]FIG. 8a shows the use of a passageway forming catheter 80 whichhas been advanced into a vein V and which has a tissue penetratingelement 82 extendable laterally therefrom, to form two (2) interstitialblood flow passageways or openings OP₁, OP₂ between the vein V and anadjacent artery A, for the purpose of bypassing an obstruction OB in theartery A in accordance with the transluminal, in situ bypass methoddescribed in copending U.S. patent application Ser. Nos. 08/730,327 and08/730,496. As shown, the axes AX₁, AX₂ of the interstitial blood flowpassageways or openings OP₁, OP₂ are initially parallel or substantiallyparallel to each other, at varying distances. It will be appreciatedthat the same openings OP₁, OP₂ could be formed by passing thepassageway forming catheter 82 through the artery A (if the obstructionis of a type which will permit such catheter 82 to be passedtherethrough) or by placing a first passageway forming catheter 82 inthe artery A and a second passageway forming catheter 82 in the vein Vas shown in FIG. 9a described herebelow.

[0086] After these bloodflow passageways or openings OP₁, OP₂ have beenformed, it may be desired to cause such interstitial blood flowpassageways or openings OP₁, OP₂ to become nonparallel (e.g., to angleinwardly toward one another, in order to promote laminar, nonturbulentblood flow through the segment of the vein V being used as the bypassconduit). To facilitate such alteration or angular disposition of theblood flow passageways or openings OP₁, OP₂, two (2) connector devices10 of the present invention will be implanted in opposite orientations,so as to exert traction upon the surrounding tissues and to cause suchmodification of the openings or passageways OP₁, OP₂, as illustrated inFIGS. 8b-8 e.

[0087] Initially, as shown in FIG. 8b, the connector device deliverycatheter 48 is advanced over a guidewire GW from the artery A, throughthe first blood flow passageway or opening OP₁, through the bypasssegment of the vein V, back through the second blood flow passageway oropening OP₂, and into the artery A distal to the obstruction OB.

[0088] Thereafter, as shown in FIG. 8c, the delivery catheter 48 isslowly withdrawn through the second blood flow passageway or opening OP₂while the distal connector device 10 is implanted within the secondblood flow passageway or opening OP₂ in the orientation shown in FIG.8c.

[0089] Thereafter, as shown in FIG. 8d, the delivery catheter 48 isfurther withdrawn through the first blood flow passageway or openingOP₁, while the proximal connector device 10 is implanted in the firstblood flow passageway or opening OP₁ in the opposite orientation shownin FIG. 8d.

[0090] Such implantation of the two connector devices 10 in opposingorientation causes traction to be exerted on the surrounding tissue andresults in angulation of the blood flow passageways or openings OP₁, OP₂such that the axes AX₁, AX₂ are no longer substantially parallel to eachother, but rather are angled toward each other as shown in FIG. 8e,thereby lessening the potential for disruption or turbulence of blood asit flows through the blood flow passageways or openings OP₁, OP₂ in themanner indicated by the arrows on FIG. 8e.

[0091] ii. Methods wherein two delivery catheters are used to implanttwo connector devices, in opposite orientations

[0092]FIGS. 9a-9 e and 10 a-10 j show two (2) examples of alternativeapproaches which may be used to implant two (2) of the connector devices10 in opposing directions, as was accomplished in the procedure shown inFIGS. 8a-8 e described hereabove. In these alternative approaches two(2) delivery catheters are used to deliver and implant the two (2)connector devices 10, as shown.

The Method Shown in FIGS. 9 a-9 e

[0093]FIG. 9a shows the use of a passageway forming catheter 80 whichhas been advanced into a vein V and which has a tissue penetratingelement 82 extendable laterally therefrom, to form two (2) interstitialblood flow passageways or openings OP₁, OP₂ between the vein V and anadjacent artery A, for the purpose of bypassing an obstruction OB in theartery A in accordance with the transluminal, in situ bypass methoddescribed in copending U.S. patent application Ser. Nos. 08/730,327 and08/730,496. As shown, the axes AX₁, AX₂ of the interstitial blood flowpassageways or openings OP₁, OP₂ are initially parallel or substantiallyparallel to each other.

[0094] In this particular application of the technology, it is desiredto cause the interstitial blood flow passageways or openings OP₁, OP₂ tobecome nonparallel and to angle inwardly toward one another, in order topromote laminar, non-turbulent blood flow through the segment of thevein V being used as the bypass conduit. To facilitate suchnon-parallelism or angular disposition of the blood flow passageways oropenings OP₁, OP₂, two (2) connector devices 10 of the present inventionwill be inplanted in opposite orientations, as shown in FIGS. 9b-9 e.

[0095] Initially, as shown in FIG. 9b, a first connector device deliverycatheter 48 a is advanced over a guidewire GW into the vein V, and isused to place a connector device 10 within the second blood flowpassageway or opening OP₂, between the artery A and vein V, distal tothe obstruction OB.

[0096] Thereafter, as shown in FIG. 9c, a second delivery catheter 48 bis used to place a connector device 10 within the first blood flowpassageway or opening OP2, in the opposite orientation shown in FIG. 8d.

[0097] Such implantation of the two connector devices 10 in opposingorientation causes traction to be exerted on the surrounding tissue andresults in angulation of the blood flow passageways or openings OP₁, OP₂such that the axes AX₁, AX₂ are no longer substantially parallel to eachother, but rather are angled toward each other as shown in FIG. 9e,thereby lessening the potential for disruption or turbulence of blood asit flows through the blood flow passageways or openings OP₁, OP₂ in themanner indicated by the arrows on FIG. 9e.

The Method Shown in FIGS. 10 a-10 i

[0098]FIG. 10a shows the use of a passageway forming catheter 80 whichhas been advanced into a vein V and which has a tissue penetratingelement 82 extendable laterally therefrom, to form two (2) interstitialblood flow passageways or openings OP₁, OP₂ between the vein V and anadjacent artery A, for the purpose of bypassing an obstruction OB in theartery A in accordance with the transluminal, in situ bypass methoddescribed in copending U.S. patent application Ser. Nos. 08/730,327 and08/730,496. As shown, the axes AX₁, AX₂ of the interstitial blood flowpassageways or openings OP₁, OP₂ are initially parallel or substantiallyparallel to each other.

[0099] As in the above-described examples of FIGS. 8a-8 e and 9 a-9 e,it is desired to cause the interstitial blood flow passageways oropenings OP₁, OP₂ to become nonparallel and to angle inwardly toward oneanother, in order to promote laminar, non-turbulent blood flow throughthe segment of the vein V being used as the bypass conduit. Tofacilitate such non-parallelism or angular disposition of the blood flowpassageways or openings OP₁, OP₂ two (2) connector devices 10 of thepresent invention will again be inplanted in opposite orientations.

[0100] Initially, as shown in FIGS. 10b and 10 c, a first connectordevice delivery catheter 48 a is advanced over a guidewire GW into thevein V, and is used to place a connector device 10 within the secondblood flow passageway or opening OP₂, between the artery A and vein V,distal to the obstruction OB.

[0101] Thereafter, as shown in FIGS. 10d-10 g, a guidewire GW isadvanced into the atrery A such that the distal end of the guidewire GWis located next to the proximal passageway or opening OP₁. A guidewirecaptureing catheter 100 having a guidewire capturing apparatus 102advanceable therefrom, is advanced into the vein V adjacent to the firstpassageway or opening OP₁, and the guidewire capturing apparatus 102 isadvanced through the first passageway or opening OP₁ and is used tocapture the guidewire GW at a location near its distal end, as shown.Thereafter, the guidewire capturing apparatus 102 and/or catheter 100is/are manipulated and/or retracted to pull the distal end of theguidewire GW through the first passageway or opening OP₁ such that thedistal end of the guidewire GW is positioned within the vein V, distalto the first passageway or opening OP₁, as shown. The guidewirecapturing apparatus used in this step of the procedure may be any typeof member or apparatus which is useable for this purpose, including butnot limited to intraluminal snares and graspers of the type well knownin the field of interventional radiology. Examples of commerciallyavailable snares or graspers which may be useable or modifiable for thisapplication include the Cordis BI PAL formable/torquable disposablebiopsy forceps(Cordis—, Miami, Fla.); the BYCEP P. C. pre-curved biopsyforcep (Mansfield-Boston Scientific Corporation, Watertown, Mass.); theIntravascular Snare (Cook, Inc., Bloomington, Ind.); and the MicrovenaRetrieval Snare (Microvena, Corporation, White Bear Lake, Minn.).

[0102] Thereafter, as shown in FIGS. 10h-10 j, a second deliverycatheter 48 b is advanced through the artery A, over the guidewire GW,and through the first passageway or opening OP₁ and is used to place asecond connector device 10 within the first blood flow passageway oropening OP₁, in the opposite orientation shown in FIG. 8d.

[0103] Such implantation of the two connector devices 10 in opposingorientation causes traction to be exerted on the surrounding tissue andresults in angulation of the blood flow passageways or openings OP₁, OP₂such that the axes AX₁, AX₂ are no longer substantially parallel to eachother, but rather are angled toward each other as shown in FIG. 10e,thereby lessening the potential for disruption or turbulence of blood asit flows through the blood flow passageways or openings OP₁, OP₂ in themanner indicated by the arrows on FIG. 10e.

[0104] F. Use of a Partially Covered Connector Device to Block Outflowthrough Side Branches which Emanate From the Anatomical Conduit(s)

[0105]FIGS. 11a-11 e show an example of a procedure wherein a single,partially covered, connector device 10 (covered) is used tosimultaneously a) maintain flow through first and second bloodflowpassageways or openings OP₁, OP₂ and b) block the outflow of bloodthrough venous side branches SB which emanate from the segment of vein Vbeing used as an in situ bypass conduit.

[0106] Initially, as shown in FIG. 11a, a passageway forming catheter 80is utilized to form first and second bloodflow passageways or openingsOP₁, OP₂ between an artery A and vein V. As discussed hereabove withreference to FIGS. 8a-8 d, 9 a-9 e, and 10 a-10 j, the passagewayforming catheter 80 may alternatively be passed into the artery A orinto both the artery A and vein V to create the form these bloodflowpassageways or openings OP₁, OP₂ having axes AX₁, AX₂ which aresubstantially parallel to each other, as shown in FIG. 11a.

[0107] Thereafter, as illustrated in FIG. 11b a guidewire GW is advancedthrough the artery A, through the first passageway or opening OP₁,through the adjacent segment of the vein V, and through the secondpassageway or opening OP₂, such that the distal end of the guidewire GWis located in the artery A downstream of the obstruction OB. A connectordevice delivery catheter 48 having the a single, partially covered,connector device 10 (covered) loaded therein is then advanced over theguidewire until the distal end of the delivery catheter 48 is also inthe artery A, downstream of the obstruction OB, as shown.

[0108] Thereafter, as shown in FIGS. 11c-11 d, the connector device 10(covered) is advanced out of the distal end of the delivery catheter 48as the delivery catheter is slowly retracted. This results in the singleconnector device 10 (covered) being implanted such that its distalannular member 12 b is positioned within the artery A downstream of theobstruction, its proximal annular member 12 a is positioned within theartery A upstream of the obstruction, and its strut members 14 extendthrough the first and second passageways or openings OP₁, OP₂, andthrough the segment of vein V being used as the in situ bypass conduit.

[0109] As shown in FIG. 1e, the partial covering 59 disposed on one sideof the strut members 14 of the connector device 10 (covered) ispositioned in contact with the adjacent wall of the vein V so as toprevent blood from flowing into any venous side branch SB which emanatesfrom that portion of the vein V. Additionally, the partial covering 59blocks the flow of venous return through the portion of the vein V beingused as the in situ bypass conduit. Also, as shown, this disposition ofa single, partially covered, two-annular-member connector device 10(covered) exerts traction upon the surrounding tissue so as to cause theaxes AX₁,AX₂ of the passageways or openings OP₁, OP₂ to angle inwardlysuch that they are no longer parallel. This serves to minimizeturbulence of the blood flowing through this bypass conduit.

[0110] G. Implantation of the Connector Devices within BifurcatedAnatomical Conduits

[0111]FIG. 12 shows an example of the manner in which atwo-annular-member connector device 10 of the present invention may beimplanted within a bifurcated vessel. As shown, the main vessel MVbifurcates into a first branch BR1 and a second branch BR2. Theconnector device 10 is positioned such that its proximal annular member12 a is in the main vessel MV, its distal annular member 12 b is in thesecond branch vessel BR2 and its strut members 14 extend therebetween.

[0112] H. Connector Devices having Additional Annular Members

[0113] It will be appreciated that the two-annular-member connectordevice 10 has at least two annular members 12 a, 12 b, but may includemore. Likewise, the three-annular-member connector device 10′ has atleast three annular members 12 a, 12 b, 12 c, but may include more.Examples of three-annular-member connector devices which incorporatemore that thee annular members 12 a, 12 b, 12 c, are shown in FIGS. 15and 16. As shown, depending on the positioning of the device 10′following implantation, the additional proximal, distal or medialannular members 12 a, 12 b, 12 c may serve to provide additionalscaffolding or support for the anatomical conduits AC₁, AC₂ or theinterstitial passageways formed therebetween.

[0114] I. Variable Positioning of the Connector Devices to AccommodateAnatomical Differences and/or to Effect Specialized TherapeuticApplications

[0115] The connector devices 10, 10′, 10 (covered) may be implanted atvarious locations and/or positions to achieve the desired therapeuticresult (e.g., to facilitate flow of body fluid in the desireddirection(s) through the desired conduits/passageways). As shown in manyof the figures, including FIGS. 1a, 1 b, 8 e, the connector device 10,1O′, 10 (covered) may be implanted such that its opposite ends extendinto the first and second anatomical conduits AC₁, AC₂ and itsmidportion extends through a passageway which has been formed betweenthose anatomical conduits. In other applications, as illustrated inFIGS. 15-17, the connector device 10, 10′, 10 (covered) may be implantedsuch that it extends through multiple interstitial passageways, and/orso that it does not extend into specific regions of the anatomicalconduits AC₁, AC₂.

[0116] It is to be further understood that the diameters or sizes of theannular members 12 a, 12 b, 12 c of a single device 10, 10′, 10(covered)may vary when in their radially expanded states. Such variation in thediameters or sizes of the annular members 12 a, 12 b, 12 c may beutilized to accommodate vessels or passageways of varying size. (e.g., avein of one diameter and an adjacent artery of another diameter).

[0117] J. A Method for Coronary Revascularization within the Trangle ofBrouck-Moscheau Using Connector Devices of the Present Invention

[0118]FIG. 18 is a diagram of a portion of the coronary vasculatureknown as the Triangle of Brouck-Moscheau. The Triangle ofBrouck-Moscheau is defined by the left anterior descending oronaryartery LAD, the circumflex coronary artery CIR, the anteriorinterventricular vein AIV and the great cardiac vein, GCV, as shown. Inthe case illustrated in FIG. 18, an obstruction OB, such as a build-upof atherosclerotic plaque, is found in the proximal portion of the leftanterior descending artery LAD. A revascularization procedure has beencarried out to bypass such obstruction OB in the left anteriordescending artery LAD by forming a first interstitial passageway oropening OP₁ between the circumflex artery CX and the Great Cardiac VeinGCV, and a second interstitial passageway or opening OP₂ between theAnterior Interventricular Vein AIV and the Left Anterior Decendingartery LAD, downstream of the obstruction OB. A first lumen blockingmember 50 a has been placed within the great cardiac vein GCV, proximalto the first passageway or opening OP, and a second lumen blockingmember 50 b has been placed within the anterior interventricular veinAIV, distal to the second passageway or opening OP₂ such that arterialblood from the circumflex artery CIR will flow through the first bloodflow passageway 10 a, through the great cardiac vein GCV, through theanterior interventricular vein AIV and into the left anterior descendingartery LAD, downstream of the obstruction. One connector device of thepresent invention 10 has been implanted, in a generally U-shapedconfiguration, within the first passageway or opening OP₁ and anotherconnector device 10 has been implanted, in a generally serpentine or “S”shaped configuration within in the second interstitial passageway oropening OP₂. These connector devices serve to maintain patency andallignment of the passageways or openings OP₁, OP₂ such that blood willcontinue to freely flow through the adjacent segment of the GreatCardiac Vein GCV/Anterior Interventricular Vein AIV, thereby bypassingthe obstruction OB and providing restored arterial bloodflow to theportion og the Left Anterior Decending artery downstream of theobstruction.

[0119] The connector device 10 positioned in the first passageway oropening OP₁ may be preformed to the desired “U” and expelled from adelivery catheter which has been advanced into the Great Cardiac VeinGCV and at least partially through the first passageway of opening OP₁,such that the connector 10 will resiliently assume the “U” configurationshown in FIG. 17. The other connector device positioned within thesecond passageway or opening OP₂ may be preformed to a serpentine or “S”shaped configuration and may be implanted by the technique shown inFIGS. 5a-5 c and described in detail hereabove.

[0120] It will be appreciated that the invention has been describedhereabove and shown in the drawings with reference to certain presentlypreferred embodiments or examples only and no attempt has been made toexhaustively describe all possible embodiments and examples of theinvention. Indeed, those skilled in the relevant art will understandthat numerous modifications may be made to the above-describedembodiments and examples without departing from the intended spirit andscope of the invention, and it is intended that all such modificationsbe included within the scope of the following claims.

What is claimed is:
 1. A device for facilitating flow fluid between afirst opening formed in an anatomical conduit and a second openingformed in an anatomical conduit, said device comprising: at least oneproximal annular member and at least one distal annular member, each ofsaid annular members having a radially compact configuration and aradially expanded configuration; at least one strut member connected toand extending between said proximal and distal annular members, said atleast one strut member having a pre-expansion configuration and apost-expansion configuration; said device being initially transluminallydeliverable with its annular members in their radially collapsedconfigurations and said at least one strut member is in itspre-expansion configuration; and, said device being thereafterimplantable with its annular members are in their radially expandedconfigurations and said at least one strut member is in itspost-expansion configuration.
 2. The device of claim 1 wherein theproximal and distal annular members are coaxially positioned duringtransluminal delivery of the device.
 3. The device of claim 1 whereinthe proximal and distal annular members have different longitudinal axesafter the device has been implanted.
 4. The device of claim 1 whereinsaid at least one strut member comprises a plurality of strut members.5. The device of claim 2 having 4 to 8 strut members.
 6. The device ofclaim 2 wherein said strut members are spaced apart from each other anddisposed about a central axis when the device is in its implantated,such that a hollow channel is defined within said strut members.
 7. Thedevice of claim 1 wherein said at least one strut member is formed ofresilient material such that it remains in its pre-expansionconfiguration when radially constrained, but will assume itspost-expansion configuration when radially unconstrained.
 8. The deviceof claim 7 wherein said resilient material is selected from the group ofresilient materials consisting of: spring metal; a resilient polymer;and, a shape memory alloy.
 9. The device of claim 1 wherein said atleast one strut member(s) is/are formed of malleable material.
 10. Thedevice of claim 10 wherein said malleable material is selected from thegroup of malleable materials consisting of: plastically deformablemetal; and, plastically deformable polymer.
 12. A system comprising thedevice of claim 10 in combination with: a pressure-exerting memberpositioned within said device and useable to cause the annular membersto radially expand and the at least one strut member to deform from itspre-expansion configuration to its post-expansion configuration.
 13. Thesystem of claim 12 wherein said pressure-exerting device is a balloonwhich has a curved configuration when inflated to deform said strutmembers to a curvilinear post-expansion configurations.
 14. The deviceof claim 1 wherein said annular members are self-expanding.
 15. Thedevice of claim 10 wherein said self-expanding annular members areformed of resilient material and are biased to their radially expandedconfigurations.
 16. The device of claim 15 wherein said resilientmaterial is selected from the group consisting of: spring metal;resilient polymer; and, shape memory alloy.
 17. The device of claim 1wherein said annular members are pressure-expandable.
 18. The device ofclaim 17 wherein said pressure-expandable annular members are formed ofmalleable material capable of being plastically deformed from theirradially compact configurations to their radially expandedconfigurations.
 19. The device of claim 18 wherein said malleablematerial is selected from the group of malleable materials consistingof: plastically deformable metal; and plastically deformable polymer.11. The device of claim 1 wherein said at least one strut member hasfirst and second ends, said first and second ends being fused to saidfirst and distal annular members.
 12. The device of claim 16 whereinsaid at least one strut member has first and second ends which areconnected to said first and distal annular members by flexibleconnections.
 13. The device of claim 13 wherein loops are formed on thefirst and second ends of said at least one strut member, and portions ofsaid first and distal annular members are captured within said loops, tothereby form said flexible connections between the ends of said at leastone strut member and first and distal annular members.
 15. The device ofclaim 1 wherein the curvilinear post-expansion configuration of said atleast one strut member is a serpentine configuration.
 16. The device ofclaim 1 wherein the curvilinear post-expansion configuration of said 10at least one strut member is a generally U shaped configuration.
 17. Thedevice of claim 2 further comprising: a plurality of transverse strutconnector members formed between adjacent ones of said strut members.18. The device of claim 2 wherein outer ones of said strut members havea longer radius of curvature than inner ones of said strut members whenthe device is in its second condition, and wherein said outer ones ofsaid strut members are longer in length than said inner ones of saidstrut members, said outer ones of said strut members having at least onewave formed therein while the device is in its first condition.
 19. Thedevice of claim 1 further comprising a pliable covering formed on atleast a portion of said device.
 20. The device of claim 19 wherein saidpliable covering is a generally cylindrical covering formed about saiddevice, said cover defining a hollow lumen which extends longitudinallythrough the device.
 21. The device of claim 19 wherein at least oneflow-through opening is formed in said pliable covering.
 22. The deviceof claim 19 wherein said pliable covering is formed transversely acrossthe device to block flow of body fluid.
 23. The device of claim 1wherein said at least one strut member has a post-expansionconfiguration which is multicurvate, such that said proximal and distalannular members may be positioned at spaced-apart locations in the sameanatomical conduit and said at least one strut member may extend throughsaid first and second openings and through a segment of an adjacentsecond anatomical conduit.
 24. The device of claim 1 wherein at leastsome of the proximal and distal annular members are of differing sizewhen in their radially expanded configurations.
 25. A device forfacilitating fluid flow between the lumen of a first anatomical conduitwhich has a first opening formed therein, and the lumen of a secondanatomical conduit which has a second opening formed therein, saiddevice comprising: at least one proximal annular member, at least onedistal annular member and at least one medial annular member, each ofsaid annular members having a radially compact configuration and aradially expanded configuration; at least one first strut memberconnected to and extending between said proximal and medial and medialannular members, said at least one first strut member having apre-expansion configuration and a post-expansion configuration; at leastone second strut member connected to and extending between said medialand distal annular members, said at least one second strut member havinga pre-expansion configuration and a post-expansion configuration; saiddevice being initially transluminally deliverable with its annularmembers in their radially collapsed configurations and said first andsecond strut members in their pre-expansion configurations; and, saiddevice being thereafter implantable with its annular members in theirradially expanded configurations and its first and second strut membersin their post-expansion configurations.
 26. The device of claim 25wherein the proximal, distal and medial annular members are coaxiallypositioned during transluminal delivery of the device.
 27. The device ofclaim 26 wherein the proximal and distal annular members have differentlongitudinal axes after the device has been implanted.
 28. The device ofclaim 25 wherein said at least one first and second strut memberscomprise a plurality of first and second strut members.
 29. The deviceof claim 28 having 4 to 8 first strut members and 4-8 second strutmembers.
 30. The device of claim 25 wherein adjacent ones of said firstand second strut members are spaced apart from each other and disposedabout a central axis when the device is implanted, such that a hollowchannel is defined within said strut members.
 31. The device of claim 25wherein said first and second strut members are formed of resilientmaterial such that they remain in their pre-expansion configurationswhen radially constrained, but will assume their post-expansionconfigurations when radially unconstrained.
 32. The device of claim 31wherein said resilient material is selected from the group of resilientmaterials consisting of: spring metal; a resilient polymer; and, a shapememory alloy.
 33. The device of claim 25 wherein said first and secondstrut members are formed of malleable material.
 34. The device of claim33 wherein said malleable material is selected from the group ofmalleable materials consisting of: plastically deformable metal; and,plastically deformable polymer.
 35. The device of claim 25 whein atleast some of said proximal, distal and medial annular members are ofdifferent size when in their radially expanded configurations.
 36. Asystem comprising the device of claim 33 in combination with: apressure-exerting member positioned within said device and useable tocause the device to deform and become implanted such that its annularmembers are in their radially expanded configurations and its first andsecond strut members in their post-expansion configurations.
 37. Thesystem of claim 36 wherein said pressure-exerting device is a balloonwhich has a curved configuration when inflated to deform said first andsecond strut members to their curved post-expansion configurations. 38.The device of claim 25 wherein said annular members are self-expanding.39. The device of claim 38 wherein said self-expanding annular membersare formed of resilient material and are biased to their radiallyexpanded configurations.
 40. The device of claim 39 wherein saidresilient material is selected from the group consisting of: springmetal; resilient polymer; and, shape memory alloy.
 41. The device ofclaim 25 wherein said annular members are pressure-expandable.
 42. Thedevice of claim 41 wherein said pressure-expandable annular members areformed of malleable material capable of being plastically deformed fromtheir radially compact configurations to their radially expandedconfigurations.
 43. The device of claim 42 wherein said malleablematerial is selected from the group of malleable materials consistingof: plastically deformable metal; and plastically deformable polymer.44. The device of claim 25 wherein said first and second strut membershave first and second ends, the first and second ends of said firststrut members being fused to said proximal and medial annular membersand the first and second ends of said second strut members being fusedto said medial and distal annular members.
 45. The device of claim 44wherein said first and second strut members have first and second ends,the first and second ends of said first strut members are connected tosaid proximal and medial annular members by flexible connections and thefirst and second ends of said second strut members are connected to saidmedial and distal annular members by flexible connections.
 46. Thedevice of claim 45 wherein loops are formed on the first and second endsof said first and second strut members, and portions of said annularmembers are captured within said loops, to thereby form said flexibleconnections between the ends of said strut members and said annularmembers.
 47. The device of claim 25 wherein the post-expansionconfiguration of said at least one first strut member is curved in afirst direction and the post-expansion configuration of said at leastone second strut member is curved in a second direction, such that saidfirst and second strut members combine to provide a serpentineconfiguration.
 48. The device of claim 25 further comprising: aplurality of transverse strut connector members formed between adjacentones of said strut members.
 49. The device of claim 25 wherein outerones of said strut members have a longer radius of curvature than innerones of said strut members when the device is implanted, and whereinsaid outer ones of said strut members are longer in length than saidinner ones of said strut members, said outer ones of said strut membershaving at least one wave formed therein while in their pre-expansionconfigurations.
 50. The device of claim 25 further comprising a pliablecovering formed on at least a portion of said device.
 51. The device ofclaim 50 wherein said pliable covering is a generally cylindricalcovering formed about said device, said cover defining a hollow lumenwhich extends longitudinally through the device.
 52. The device of claim50 wherein at least one flow-through opening is formed in said pliablecovering.
 53. The device of claim 50 wherein said pliable covering isformed transversely across the device to block flow of body fluid. 54.The device of claim 25 wherein said first and second strut memberscombine to have a post-expansion configuration which is multicurvate,such that said proximal and distal annular members may be positioned atspaced-apart locations in the same anatomical conduit and said strutmember may extend through said first and second openings and into asegment of an adjacent second anatomical conduit with said medialannular member being located within said secon anatomical conduit.